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End Stage Renal DiseasePhase 2PRIMENCT01286012

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients

A Phase 2 study testing Soluble Ferric Pyrophosphate in liquid bicarbonate, Erythrocyte Stimulating Agent (ESA) and Intravenous (IV) Iron in people with End Stage Renal Disease, run by Rockwell Medical Technologies, Inc. at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Renal Disease
What is being tested?
Soluble Ferric Pyrophosphate in liquid bicarbonate, Erythrocyte Stimulating Agent (ESA) and Intravenous (IV) Iron
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
23 sitesin 2 countries
Study dates
Jan 2011to Jan 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Male and female subjects ≥ 18 years of age.
  2. End-stage renal disease undergoing maintenance hemodialysis 3 to 4 times a week for at least 4 months and expected to remain on this schedule and be able to complete the study. Subjects on a cadaveric transplant list need not be excluded for this reason unless there is an identified donor.
  3. Mean Hgb in the range of ≥ 9.5 to ≤ 12.0 g/dL during screening.
  4. The difference between the maximum and minimum Hgb values during screening does not exceed 1.0 g/dL.
  5. Mean ferritin ≥ 200 to ≤ 1000 µg/L during screening.
  6. Mean TSAT ≥ 15% to ≤ 40% during screening.
  7. Any and all serum albumin measured during the 2 months preceding randomization must be ≥ 3.0 g/dL.
  8. Prescribed ESA dosing remaining in the range of ≥ 4,000 to ≤ 45,000 U/week epoetin or ≥ 12.5 to ≤ 200 µg/week darbepoetin during the 6 weeks preceding randomization.
  9. Required IV iron at any time in the 6 months preceding randomization.

Main Exclusion Criteria:

  1. Vascular access for dialysis is a catheter.
  2. During the 6 months prior to randomization, infection of the vascular access to be used at the time of randomization.
  3. Received a total of > 600 mg IV iron during the 6 weeks prior to randomization.
  4. Received any amount of IV or oral iron during the 2 weeks prior to randomization.
  5. Change in prescribed ESA dose:
  6. Any change in prescribed ESA dose within 4 weeks prior to randomization.
  7. The prescribed ESA dose at the time of randomization is > 25% higher or lower than the prescribed dose at 6 weeks prior to randomization.
  8. Change in prescribed type of ESA (e.g., epoetin vs. darbepoetin) or route of administration within 6 weeks prior to randomization.
  9. Actual ESA dosing missed or withheld for a cumulative total of ≥ 1 week for any reason during the 6 weeks prior to randomization.
  10. Known cause of anemia other than anemia attributable to renal disease (e.g., sickle cell disease, thalassemia, pure red cell aplasia, hemolytic anemia, myelodysplastic syndrome, etc.)
  11. Scheduled kidney transplant or a donor has been identified but the transplant has not been scheduled.
  12. Known ongoing inflammatory disorder (other than Chronic Kidney Disease), such as systemic lupus erythematosus, rheumatoid arthritis, other collagen-vascular diseases, etc.
  13. Known active tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study. Subjects with hepatitis C, in the absence of cirrhosis, are not excluded from participation in the study if Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels are below 2 times the upper limit of normal on a consistent basis during the 2 months preceding randomization.
  14. Occult tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patient's participation in this study.
  15. Cirrhosis of the liver based on histological criteria or clinical criteria (e.g., presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy).

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

United States22 sites

  • Investigator

    Albany, Georgia, 31702

  • Investigator

    Birmingham, Alabama, 35211

  • Investigator

    Colorado Springs, Colorado, 80909

  • Investigator

    Columbia, Tennessee, 38401

  • Investigator

    Columbus, Mississippi, 39705

  • Investigator

    Duncanville, Texas, 75137

  • Investigator

    Granada Hills, California, 91344

  • Investigator

    Greenville, Texas, 75402

  • Investigator

    Hayden, Idaho, 83835

  • Investigator

    Kansas City, Missouri, 64114

  • Investigator

    Las Vegas, Nevada, 89120

  • Investigator

    Lexington, North Carolina, 27292

  • Investigator

    Louisville, Kentucky, 40202

  • Investigator

    Miami, Florida, 33128

  • Investigator

    Miami, Florida, 33173

  • Investigator

    New Orleans, Louisiana, 70122

  • Investigator

    Paterson, New Jersey, 07503

  • Investigator

    San Antonio, Texas, 78215

  • Investigator

    San Antonio, Texas, 78221

  • Investigator

    St. George, Utah, 84770

  • Investigator

    Taylorsville, Utah, 84118

  • Investigator

    Tempe, Arizona, 85284

Other trials in United States

Puerto Rico1 site

  • Investigator

    Fajardo, 00738

Other trials in Puerto Rico

About this study

Official title: Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate: The PRIME Study

The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without iron.

Being tested
Soluble Ferric Pyrophosphate in liquid bicarbonate, Placebo: Conventional liquid bicarbonate, Erythrocyte Stimulating Agent (ESA), Intravenous (IV) Iron
Keywords
End Stage Renal Disease, Hemodialysis, SFP
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soluble Ferric Pyrophosphate in liquid bicarbonateDrug

    Also called SFP

    Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.

  • Placebo: Conventional liquid bicarbonateDrug

    Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking SFP at every dialysis session, for a total duration of 36 weeks.

  • Erythrocyte Stimulating Agent (ESA)Drug

    ESA was administered according to the recommendation of a blinded central anemia management center (CAMC) based on the weekly hemoglobin value and its rate of change.

  • Intravenous (IV) IronDrug

    Approved IV iron preparations were administered per a protocol driven algorithm when patients serum ferritin value decreased below 200 ug/L.

Study groups in NCT01286012
Study groupRoleWhat they receive
SFP in liquid bicarbonateActive comparatorNot described
Receives: Drug: Soluble Ferric Pyrophosphate in liquid bicarbonate; Drug: Erythrocyte Stimulating Agent (ESA); Drug: Intravenous (IV) Iron
Placebo: Conventional Liquid BicarbonatePlacebo comparatorControl concentrate lacking SFP does not contain SFP (total iron = 0)
Receives: Drug: Placebo: Conventional liquid bicarbonate; Drug: Erythrocyte Stimulating Agent (ESA); Drug: Intravenous (IV) Iron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Percent Change From Baseline in ESA Dose Required to Maintain Hemoglobin in the Target Range, Adjusted for Hgb.

    The statistical endpoint is the change from baseline between groups at End of Treatment, where the baseline prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the two-week period of time immediately prior to randomization. The end-of-treatment prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the last two weeks of the treatment period.

    Measured: Hemoglobin measured weekly and serum ferritin and Transferrin Saturation (TSAT) determined every other week; ESA dose recorded at each visit for 36 weeks.

Secondary outcomes (4)

  1. The Distribution of Changes From Baseline in the Prescribed ESA Dose Between the Two Treatment Arms

    The change from baseline in prescribed ESA dose at end-of-treatment was categorized as being greater than or equal to 25%, 10 to less than 25%, -10 to 10%, greater than -25 to -10% and less than or equal to -25%. The number of subjects in each treatment group that fit each category was compared.

    Measured: ESA dose is monitored and recorded at each dialysis session for 36 weeks.

  2. Stability of Hemoglobin Over Time (Maintenance of Hemoglobin Between 9.5-11.5 g/dL.

    The number of patients in each treatment group who had maintained their hemoglobin between 95 and 115 grams/liter at the end of treatment was quantified.

    Measured: 36 weeks

  3. The Amount of Supplemental Intravenous (IV) Iron Needed During Study Participation.

    The absolute amount of IV iron administered to subjects in each treatment group was divided by the number of weeks on study and the number of subjects per treatment group such that the mean dose of IV iron (mg) per week per subject (for the entire treatment group) was calculated.

    Measured: 36 weeks

  4. Comparison of Iron Delivery to the Erythron From Baseline to End of Treatment Between the Treatment Groups.

    Iron delivery to the erythron was estimated by Hgb generation in response to erythropoietin (ERI, calculated as ESA dose/Hgb). In addition, ERI was also divided by body weight in kilograms to obtain a modified ERI (ERI/kg).

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01286012
Sponsor's protocol ID
NIH-FP-01 PRIME
Acronym
PRIME
Status last verified
Aug 2018
First submitted
18 Jan 2011
Last updated
1 Oct 2018
Data monitoring committee
No

Publications

  • Gupta A, Lin V, Guss C, Pratt R, Ikizler TA, Besarab A. Ferric pyrophosphate citrate administered via dialysate reduces erythropoiesis-stimulating agent use and maintains hemoglobin in hemodialysis patients. Kidney Int. 2015 Nov;88(5):1187-94. doi: 10.1038/ki.2015.203. Epub 2015 Jul 8.

    PubMed 26154926

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Soluble Ferric Pyrophosphate in liquid bicarbonate, Erythrocyte Stimulating Agent (ESA) and Intravenous (IV) Iron in people with End Stage Renal Disease, run by Rockwell Medical Technologies, Inc. at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percent Change From Baseline in ESA Dose Required to Maintain Hemoglobin in the Target Range, Adjusted for Hgb. (time frame: Hemoglobin measured weekly and serum ferritin and Transferrin Saturation (TSAT) determined every other week; ESA dose recorded at each visit for 36 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01286012, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2018.

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